Quality Engineer III

LanceSoft Inc; North Haven (CT); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading workforce management firm in North Haven, CT is seeking a Quality Engineer to support product development and quality assurance projects. The role requires a BS degree in Engineering, at least 7 years of experience in quality or design engineering, particularly in the medical device field. Responsibilities include managing QA teams, conducting failure analysis, and ensuring compliance with industry standards. This position offers the opportunity to work with various clients in the pharmaceutical sector.

Qualifications

• Minimum 7 years’ experience in design, manufacturing, or quality engineering (medical device experience preferred).
• Experience in a regulated environment.
• Proficiency in analytical tools and methods.

Responsibilities

• Perform Quality Engineering functions in support of product development projects.
• Ensure proper specifications and inspections of components and devices.
• Manage QA teams and oversee Quality Engineering processes.

Skills

Quality Engineering

Statistical Analysis

Failure Analysis

Risk Management

Education

BS degree in Engineering, Math or Physical Science

Tools

Minitab

Design of Experiments (DOE)

Job description

Energy, it defines LanceSoft. Consider our unique ‘keep apace’ operational culture, the spirited lot of hand‑picked professionals, our ‘up‑to‑the‑minute’ knowledge base, together they form a dynamic mix of value‑generating characteristics that help us delve into the heart of a problem to deliver precise services and solutions – repeatedly.

In business since 2000, LanceSoft is a reputed and credible Contingent Workforce Management Services firm that has established itself as a pioneer in providing highly scalable workforce solutions and exceptionally competent global Pharmaceutical & IT services to a diverse set of customers across various industries around the globe. LanceSoft is headquartered out of the Washington DC Metropolitan (Herndon, VA) and operates out of various locations in the US, Canada and India.

LanceSoft specializes in recruiting and retaining top clinical research & scientific talent for leading pharmaceutical and biotech companies. Our staff maintains a commitment to excellence by developing lasting and professional relationships with both hiring managers and job seekers throughout the industry. Our dedicated & professional Account Management and experienced delivery team is well versed in industry specific requirements and market trends.

We provide staffing solutions specializing in all areas of the clinical development process for the Pharmaceutical, Biotechnology, and Medical Device industries. We understand the clinical trial process from Phase I through Phase IV. We provide the most experienced, highly screened candidates on a contract, contract to hire, or permanent hire basis.

Our Clientele: Johnson & Johnson, Merck, Pfizer, Novartis, Purdue, Eisai, Aetna, Becton & Dickinson, Actavis Pharmaceutical, Shire Pharmaceutical.

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Job Description

Performs Quality Engineering functions in support of projects associated to product development/change including design verification (design for six sigma), reliability engineering, component specification / approval, process evaluation and nonconforming product analysis in a project team environment. Ensure that component and finished devices are properly specified and inspected, and the associated manufacturing processes are properly designed, analyzed and validated. Evaluate component and sub‑assembly subcontractors to ensure device quality and conformance to standards and regulations. Perform failure analysis to prevent or correct component and product failures as well as other risk management activities. Manage QA extended teams to ensure adequate support for all projects. Oversee and provide leadership for Quality Engineers, Associate Quality Engineers and other personnel as necessary. Tracking timelines and facilitating the required Quality Engineering Tools. Providing guidance to Divisional Quality Engineers and Associate Engineers with project and assuring proper and consistent implementation of the quality engineering tools. Provide support to other quality groups to assure efficient completion of project requirements.

Qualifications

Education: BS degree in Engineering, Math Physical Science

Additional Information

Experience: Minimum 7 years’ experience in design, manufacturing, or quality engineering position (medical device experience preferred). Three years of experience can be substituted for an advanced degree in related discipline. Experience with analytical tools and methods, including statistics (minitab preferred), DOE, and the use of computer software packages related to design, development and manufacturing. Statistical Quality control/statistical process control, design of experiments, failure mode and effects analysis. Experience in a regulated environment.